Tissular LesionECHOFUSIONNCT02563444
Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
A study testing Ultrasound fusion guiding system - TUS A-500 (Aplio 500) in people with Tissular Lesion, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tissular Lesion
- What is being tested?
- Ultrasound fusion guiding system - TUS A-500 (Aplio 500)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 years
- male or female
- women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual
- Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ
- patient signed an informed consent
Who cannot join
- Contraindications to the use of X-rays (pregnancy)
- Patients using vital electronic devices (eg: pacemaker or defibrillator)
- Subject under judicial protection
- Subject under tutorship or curatorship
- Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).
Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).
- Conditions
- Tissular Lesion
- Being tested
- Ultrasound fusion guiding system - TUS A-500 (Aplio 500)
- Keywords
- Diagnostic (Biopsy) or Therapeutic Procedure (Infiltration, Ablation)
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound fusion guiding system - TUS A-500 (Aplio 500)Device
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound fusion guiding system | Experimental | Not described Receives: Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed)
Measured: time of the procedure
Secondary outcomes (2)
distance between the center of the target and the extension of the spinal needle (perpendicular line to this projection through the center of the lesion)
Measured: time of the procedure
overall satisfaction score
Measured: time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tissular LesionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afshin GANGI, MD, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563444
- Sponsor's protocol ID
- 2014-A00413-44
- Acronym
- ECHOFUSION
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2015
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bing F, Vappou J, Breton E, Enescu I, Garnon J, Gangi A. Accuracy of a CT-Ultrasound Fusion Imaging Guidance System Used for Hepatic Percutaneous Procedures. J Vasc Interv Radiol. 2019 Jul;30(7):1013-1020. doi: 10.1016/j.jvir.2018.11.034. Epub 2019 Mar 25.
PubMed 30922795Garnon J, Koch G, Tsoumakidou G, Caudrelier J, Chari B, Cazzato RL, Gangi A. Ultrasound-Guided Biopsies of Bone Lesions Without Cortical Disruption Using Fusion Imaging and Needle Tracking: Proof of Concept. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1267-1273. doi: 10.1007/s00270-017-1638-9. Epub 2017 Mar 29.
PubMed 28357575
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology
- ClinicalTrials.gov ID
- NCT02563444
- Acronym / sponsor ID
- ECHOFUSION / 2014-A00413-44
- Conditions
- Tissular Lesion
- Keywords
- Diagnostic (Biopsy) or Therapeutic Procedure (Infiltration, Ablation)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).
Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound fusion guiding system | Experimental | Device: Ultrasound fusion guiding system - TUS A-500 (Aplio 500) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age>18 years
- male or female
- women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual
- Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ
- patient signed an informed consent
Key exclusion criteria (5 listed)
- Contraindications to the use of X-rays (pregnancy)
- Patients using vital electronic devices (eg: pacemaker or defibrillator)
- Subject under judicial protection
- Subject under tutorship or curatorship
- Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound fusion guiding system - TUS A-500 (Aplio 500) | Device | Ultrasound fusion guiding system |
Primary outcome
Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed)
Time frame: time of the procedure
2 secondary outcomes
distance between the center of the target and the extension of the spinal needle (perpendicular line to this projection through the center of the lesion)
Time frame: time of the procedure
overall satisfaction score
Time frame: time of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 30922795Bing F, Vappou J, Breton E, Enescu I, Garnon J, Gangi A. Accuracy of a CT-Ultrasound Fusion Imaging Guidance System Used for Hepatic Percutaneous Procedures. J Vasc Interv Radiol. 2019 Jul;30(7):1013-1020. doi: 10.1016/j.jvir.2018.11.034. Epub 2019 Mar 25.
- Results publication: PubMed 28357575Garnon J, Koch G, Tsoumakidou G, Caudrelier J, Chari B, Cazzato RL, Gangi A. Ultrasound-Guided Biopsies of Bone Lesions Without Cortical Disruption Using Fusion Imaging and Needle Tracking: Proof of Concept. Cardiovasc Intervent Radiol. 2017 Aug;40(8):1267-1273. doi: 10.1007/s00270-017-1638-9. Epub 2017 Mar 29.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afshin GANGI, MD principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound fusion guiding system - TUS A-500 (Aplio 500) in people with Tissular Lesion, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the averages (m) errors of the coordinates in the three planes of space, between the virtual and the real line of the spinal needle (comparison of ultrasound fusion data with control CT scan data achieved once the spinal needle is placed) (time frame: time of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563444, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.